FDA Approves Combination of Lynparza and Avastin as Maintenance Treatment for Advanced Ovarian Cancer

The Food and Drug Administration (FDA) has approved the combination of two targeted drugs, Lynparza (olaparib) and Avastin (bevacizumab), for patients with advanced ovarian cancer who have responded to initial treatment with platinum-based chemotherapy plus Avastin and whose disease has a specific mutation.

To be eligible for the treatment, patients must have experienced a complete or partial response to their previous therapy and have cancer that expresses homologous recombination (HRD) deficiency due to a BRCA gene mutation and/or genomic instability. This combination treatment is a maintenance therapy, designed to prevent the treated disease from worsening.

The approval was based on results from the phase 3 PAOLA-1 trial, which included patients with newly diagnosed, advanced, high-grade, serous or endometroid ovarian, fallopian tube or peritoneal cancer.

The study found that the drug combination led to a 41% reduction in the risk of disease progression or death compared with Avastin alone in this patient population. Additionally, after a median follow-up of 22.9 months, the median time until disease progression was 22.1 months and 16.6 months, respectively, with the combination and Avastin alone.

Results also showed that Lynparza was most beneficial for patients with HRD-positive tumors, including those that were BRCA-positive. In this subgroup, the median time until disease progression was 37.2 months with the Lynparza combination and 17.7 months with Avastin alone.

In those who had HRD-positive tumors without BRCA mutations, the median time until disease progression was 28.1 months with Lynparza/Avastin and 16.6 months with Avastin alone.

The most common side effects occurring in more than 20% of patients in the combination arm compared with the bevacizumab-alone arm were fatigue (53% versus 32%, respectively), nausea (53% versus 22%), high blood pressure (46% versus 60%), anemia (41% versus 10%), a low level of lymphocytes in the blood (24% versus 9%), vomiting (22% versus 11%) and joint pain (22% versus 24%).

Serious or severe side effects were reported in 57% of patients who received the addition of Lynparza to Avastin and occurred in 51% of patients on Avastin alone. Side effects that led to dose interruption occurred in 54% of patients on Lynparza plus Avastin compared with 24% of patients on Avastin alone.

Check back later to learn more about what this approval means for patients.